BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region of the mandible and fractures of the condylar basis region of the mandible.

    Recall: Z-0992-2014 · Reported February 26, 2014

    Enforcement

    Recall Number
    Z-0992-2014
    Event ID
    67396
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 26, 2014
    Initiation Date
    January 27, 2014
    Classification Date
    February 19, 2014
    Termination Date
    July 20, 2015
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417, United States

    Description

    Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region of the mandible and fractures of the condylar basis region of the mandible.

    Reason

    One lot of Matrix Mandible Short Threaded Drill Guides (part No. 03.503.043) has a gray colored band instead of a green colored band as pictured in the Technique Guide.

    Code Info

    part No. 03.503.043, lot #7908431

    Distribution

    US distribution to MI, TX, and CA.

    Quantity

    12